The present invention relates to a hemostatic material insertion device for sealing a puncture portion in a blood vessel to stop bleeding, as well as the method.
In special medical operations, such as a cardiac catheterization, a percutaneous diagnosed contract, a percutaneous transluminal coronary angioplasty (PTCA) or a percutaneous transluminal coronary reconstruction (PTCR), in general, a catheter or other device is percutaneously inserted into an artery from the inguinal region or the femoral region. After that, it is provided to the operation site, and thereby a minimally invasive operation is made.
In order to make the insertion of devices, such as catheters, easier during these operations, the arterial puncture portion must be expanded by a sheath, and followed by appropriate treatments for the completion of the operations. Additionally, after the operations, the sheath must be removed, and the puncture foramen must be closed.
Provided a puncture foramen is small, the hemostasis could be achieved simply by the application of digital pressure. However, in cases like blood vessel operations, the use of a catheter having a large diameter is much more advantageous, thus an operation is conducted using a sheath with a relatively large diameter.
However, digital pressure must be applied for a long time to achieve hemostasis of the puncture foramen after the operation using the sheath with a larger diameter. Consequently, because a patient must be immobilized until the sealing of the puncture foramen is completed, the procedure is painful and uncomfortable for the patient.
Additionally, it is not easy to seal the foramen perfectly by this procedure, and there is a tendency for the foramen to come open again after it is sealed. Therefore, the patients are required to remain in the hospital for 24 hours or longer.
Recently, a device, which stops bleeding by filling hemostatic materials, such as collagen, into the puncture foramen, was developed in order to seal the puncture foramen after the insertion of catheter, and the like, by using a sheath with a larger diameter, and the procedure of necessary operations. Thus, the device is being proposed to make it easier sealing a puncture foramen caused by cardial operations, and the like, which use a sheath with a larger diameter.
However, the hemostatic devices for puncture foramens, which have been available so far, use methods that involve pushing and filling a hemostatic material, such as collagen, into the puncture foramen. As a result, an excess of hemostatic material can easily get into an arterial canal located below the puncture foramen. In order to avoid the filling of excess hemostatic material, complicated devices are used, which require fairly high skill. Therefore it has been desired to develop a hemostatic material insertion (injection) device that is more simple and convenient to be used.
Therefore the purpose of the present invention is to provide a hemostatic material insertion device for sealing a puncture foramen by simple methods to stop bleeding, which does not require complicated devices, and with which filling arterial canals unnecessarily with excess hemostatic materials does not occur. Furthermore, another purpose is to provide methods for sealing a puncture foramen using the inventive device.
The first fundamental feature of the present invention is a hemostatic material insertion device for a puncture foramen comprising;
(a) A cartridge charged with hemostatic material, which is injected into the puncture foramen,
(b) A hollow sheath which holds the said cartridge,
(c) An ejecting piston portion pushing out the hemostatic material charged in the cartridge, which is united with the said sheath at the rear end of the sheath,
(d) A guide knob to slide the said cartridge inside the hollow sheath, and
(e) A stopping device equipped on the front end of the said hollow sheath, and the said cartridge charged with the hemostatic material is inserted into the puncture foremen by adjusting to set to the depth of the puncture foremen by means of the stopping device equipped at the front end of the sheath, then the said cartridge inserted into the puncture foramen is drawn back out of the puncture foramen by backward slide using the guide knob in the sheath, thus filling the puncture foramen with a hemostatic agent from the cartridge by means of the ejecting piston in the cartridge, united with the sheath.
Therefore, the above mentioned hemostatic material injection device of the present invention uses a cartridge which has already been charged with the hemostatic material, so that its insertion into the puncture foramen can be adjusted to the actual depth of the puncture. Thus one characteristic of this device is that unnecessary excess hemostatic material is not inserted into the inside of an arterial canal located under the puncture foramen.
For that purpose, in another embodiment of the device, the front tip of the cartridge has a tapered structure. As a result, the structure makes the insertion into the puncture foramen easier.
In addition, in a variation of the first embodiment, the tapered structure at the tip of the cartridge has been cut, and the filling of the hemostatic material, which is charged in the cartridge, into the puncture foramen is performed easily.
Based on the embodiments mentioned above, the device of a further embodiment of the present invention provides a hollow guide sheath inserted into a puncture foramen. This facilitates insertion of the cartridge charged with hemostatic material, and provides that both the hollow guide sheath and the cartridge are moved synchronously.
In short, through the hollow guide sheath inserted into a puncture foramen beforehand, the cartridge charged with the hemostatic material is inserted into the puncture foramen. After that, both the hollow guide sheath and the cartridge are drawn back out of the puncture foremen by sliding them using the guide knob in the sheath. The puncture foramen is simultaneously filled with the hemostatic agent charged in the cartridge by an ejecting piston in the cartridge.
A characteristic procedure of the hemostatic material insertion device of the present invention is one in which hemostatic material is filled into a puncture foramen. The procedure results from the fact that th e hemostatic agent charged in the cartridge is not inserted (filled) by pushing it out per se. Instead, it remains inside the puncture foramen while the cartridge, which was charged with the hemostatic material and which was originally inserted into the puncture foramen, is drawn out of the puncture foramen. Therefore, by this special characteristic, excess hemostatic material is not filled into a blood vessel under the puncture wound, and hemostasis of the puncture foramen can be accomplished with a high degree of safety.
A further embodiment of the present invention provides a method for sealing the puncture foramen to stop bleeding by using the aforementioned hemostatic material insertion device. More definitely, it provides a method to stop bleeding of the puncture foramen by inserting hemostatic material into the puncture foramen, which method has the following characteristics:
First, the cartridge charged with the hemostatic material is inserted into the puncture foramen. Next, by sliding the cartridge back within a sheath using a guide knob, the cartridge is drawn out of the puncture foramen. At the same time, the hemostatic material, charged in the cartridge within the puncture foramen is filled into the puncture foramen by means of an ejecting piston contacting the cartridge that is united with the sheath.
In a further embodiment the present invention provides a method for sealing the puncture foramen to stop the bleeding by using the aforementioned second hemostatic material insertion device. More concretely, it provides a method to stop bleeding of the puncture foramen by the hemostatic material inserted into the puncture foramen, which has the following characteristics:
First, the cartridge, charged with the hemostatic material, is inserted into the puncture foramen using a hollow sheath. Second, both the cartridge and the guide sheath are drawn out of the puncture foramen by sliding them back within the sheath using the guide knob. Simultaneously, the hemostatic material, charged in the cartridge within the puncture foramen, is filled into the puncture foramen wound by means of an ejecting piston contacting the cartridge that is united with the sheath.